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OTC Labels require:
- 1. name of product, address of manufacturer, packer, or distributor
- 2. Net contents of package
- 3. name of all active ingredients and qty
- 4. name of any habit forming drugs
- 5. adequate directions for use
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Prescritpion Labels require:
- 1. name, address and phone # of dispensing pharmacy
- 2. Patient and doctors name
- 3. prescription number and the date the prescrition was filled
- 4. name of drug, strength, qty and directions for use
- 5. name or initials of dispensing pharmacist and/or technician
- 6. Patients address
- 7. Expiration date, refill information and any precautions
- 8 "Federal law prohibits........
- 9. Package insert on selected drugs
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Package inserts require:
- 1. description of drug
- 2. Clinical Pharmacology
- 3. Indications and usage
- 4. Contraindications, precautions, warnings, and adverse reactions
- 5. Drug abuse, dependence and overdosage info
- 6. Dosage, administration and how the drug is supplied
- 7. Date of the most recent labeling revision
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Drug classes that require package inserts:(6)
- 1. Oral contraceptives
- 2. Estrogen-containing and progestational drugs
- 3. Intrauterine contraceptive devices
- 4. Diethylstilbestrol products
- 5. Accutane
- 6. Metered-Dose inhalers
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NDC code break down:
- 1. first 5 are the manufacturer
- 2. next 4 identify a specific drug
- 3. last 2 identify the package size
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Schedule I rules
- These drugs have NO accepted medicinal use in the US
- These drugs have a high abuse potential
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Schedule II rules
- These drugs may not be refilled
- Ordering and returning of these drugs requires a DEA 222 form
- These drugs have a high abuse potential, may lead to severe physical or psychological dependence
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Schedule III rules
- May be refilled 5 times in a 6 month period
- Have less potential for abuse or dependence
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Schedule IV rules
- May be refilled 5 times in a 6 month period
- Less potential for abuse or dependence
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Schedule V
Less potential for abuse or dependence
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What must Schedule II-V have?
An auxiliary label that states "Caution: Federal law probitits the transfer of this drug to any person other than the patient for whom it was prescribed"
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What form is used for the purchasing and returning of outdated CII drugs?
DEA 22 form
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What form is used to report lost or stolen controlled substances?
DEA 106 form
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What form is used to document the destruction of controlled substances?
DEA 41
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What form is needed for a pharmacy to dispense controlled substances?
DEA 224 form
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What form is needed to operate a controlled substance treatment program or compound controlled substances?
DEA 363 form
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What form is needed to maufacture or distribute controlled substances?
DEA 225 form
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Six steps to verify a DEA number
- 1. first letter should be an A or B
- 2. second letter should be the first letter of the physicians last name
- 3. Add the 1st, 3rd, and 5th number
- 4. Add the 2nd, 4th, and 6th number and multiply by 2
- 5. Add the two sums together
- 6. The last digit in the number should match the last number in the DEA
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What book compares therapeutic equivalency of drugs using an alphabetical rating system?
Approved Drug Products with Therapeutice Equivalnce Evaluations (Orange Book)
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What book contains monographs and chemical characteristics of drugs?
USP/NF US Pharmacopoeia/National Formulary
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What book is a 3 volume set:
Volume I: Drug information written for a health care provider
Volume II: Drug information written for a patient
Volume III: Therapeutic equivalency information and pharmacy law
USPDI US Pharmacopoeia Despensing Information
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What book contains a comprehensive listing of drugs and comparative drugs?
Drug Facts and Comparisions
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What book gives a listing of drugs by pricing, strengths, sizes, maufacturers, brands and generics?
Drug Topics Red Book
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What book lists injectable drug information such as compatability, storage and dosages?
Handbook on Injectable Drugs
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What book contains packet insert drug information intended for physicians and is published annually?
Physician's Desk Reference
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What book lists generic drugs in alphabetical order?
Mosbys Complete Drug Reference
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What book has the drugs listed alphabetically and provides brand, generic and the chemical names of the drugs?
American Drug Index
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What book is used to determine the compatibility of medications that will be used in an IV bag?
The Handbook of Injectable Drugs
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What sheet provides information on hazardous materials that may be in the pharmacy and also provides information on diposal, storage, safe use and clean-up of these medications?
Material Safety Data Sheets
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